Job Description

• Creation of SAS programs to Develop or Validate SDTM/Adam/TLFs.
• Provide oversight for CRO SDTM/Adam/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
• Generate and/or review of SDTM mapping specifications, annotated CRFs, Adam specifications, Define.XML documents and reviewer's guides per CDISC and FDA specifications and guidelines using standard tools and templates.
• Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
• Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
• Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
• Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
• Accountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
• Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
• Support in development and review of global standards, templates, processes, SOPs and Work Instructions.
• Partner with cross functional groups on timelines, vendor selection and CRO oversight.
• Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
• Experience in development and validation of CDISC SDTM and Adam data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
• Extensive experience of data integration.

• BS or MS in Computer Science or Biostatistics & Life Sciences.
• Minimum of 7 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
• Must possess the ability to work in a team environment.
• Excellent written, verbal, and interpersonal communication skills.
• Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
• Good knowledge of 21CFR11 and GCP.

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